FDA Adverse Event
Malfunction
Summary report: N
ACCENT MRI DR
MDR report key: 3802534
·
Received May 9, 2014
Report
- Report Number
- 2017865-2014-13748
- Event Type
- Malfunction
- Date Received
- May 9, 2014
- Date of Event
- March 26, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PLEASE RETRACT THIS REPORT 2017865-2014-13748, THIS MEDICAL DEVICE SHOULD NOT HAVE BEEN REPORTED AS A MEDICAL DEVICE REPORT (MDR).
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON INTERROGATION ERRONEOUS PARAMETER VALUES WERE DETECTED ALERT WAS GIVEN. THE BUTTON TO PROGRAM NOMINAL SETTINGS WAS PRESSED AND THE PULSE GENERATOR RESUMED NORMAL FUNCTION. THE DEVICE REMAINED IMPLANTED.
Description of Event or Problem · 1
UPON REVIEW, THE PULSE GENERATOR SHOULD NOT HAVE BEEN SUBMITTED AS A MEDICAL DEVICE REPORT (MDR).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281342 | ACCENT MRI DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST. JUDE MEDICAL, INC., CRMD | PM2224 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |